mat in the otp setting: integrating the three...

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1 MAT in the OTP Setting: Integrating the Three Approved Medications (Methadone, Buprenorphine, ER Naltrexone) Kelly J. Clark, MD, MBA Chair, OTP Workgroup American Society of Addiction Medicine

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1

MAT in the OTP Setting: Integrating the

Three Approved Medications (Methadone,

Buprenorphine, ER Naltrexone)

Kelly J. Clark, MD, MBA

Chair, OTP Workgroup

American Society of Addiction Medicine

2

Kelly J. Clark, MD, MBA,

Disclosures

Commercial

Disclosers

What Was Received Role

Grünenthal USA, Inc.

Honoraria and/or consultant fees Consultant

3

ASAM CME Committee and Reviewers

- Disclosure List

Name

Nature of Relevant Financial Relationship

Commercial Interest What was received? For what role?

Daniel P. Alford, MD, MPH, FACP, FASAM None

Adam J. Gordon, MD, MPH, FACP, FASAM, CMRO,

Chair, Activity Reviewer

None

Edwin A. Salsitz, MD, FASAM,

Acting Vice Chair

Reckitt-Benckiser Honorarium Speaker

James L. Ferguson, DO, FASAM First Lab Salary Medical Director

Dawn Howell, ASAM Staff None

Noel Ilogu, MD, MRCP None

Hebert L. Malinoff, MD, FACP, FASAM,

Activity Reviewer

Orex Pharmaceuticals Honorarium Speaker

Mark P. Schwartz, MD, FASAM, FAAFP None

John C. Tanner, DO, FASAM Reckitt-Benckiser Honorarium Speaker and consult ant

Jeanette Tetrault, MD, FACP None

4

Accreditation Statement

• The American Society of Addiction Medicine

(ASAM) is accredited by the Accreditation Council

for Continuing Medical Education to provide

continuing medical education for physicians.

5

Designation Statement

• The American Society of Addiction Medicine

(ASAM) designates this enduring material for a

maximum of 1 (one) AMA PRA Category 1 Credit™.

Physicians should only claim credit commensurate

with the extent of their participation in the activity.

Date of Release: September 30, 2014

Date of Expiration: September 30, 2017

6

System Requirements

• In order to complete this online module you will need

Adobe Reader. To install for free click the link below:

http://get.adobe.com/reader/

7

Educational Objectives

• At the conclusion of this activity participants should be able to:

Discuss the unique characteristics of Opioid Treatment Programs (OTPs)

Identify OTPs as part of the continuum of care

Understand the infrastructure available to support medication management in OTPs

Understand challenges and opportunities in integrating all three medications (methadone, buprenorphine and extended release naloxone) into the OTP setting

Discuss the clinical and operational issues related to medication choice in the OTP setting.

8

Target Audience

• The overarching goal of PCSS-MAT is to make

available the most effective medication-assisted

treatments to serve patients in a variety of settings,

including primary care, psychiatric care, and pain

management settings.

9

What is an OTP?

• An Opioid Treatment Program (OTP) provides:

multidisciplinary

outpatient-based

maintenance care of

patients with

opioid addiction,

utilizing FDA approved medication (typically

methadone), and

operating under OTP regulations and licenses

from the federal and state government

10

Why are there OTPs?

• Under federal law, patients may be treated with

scheduled narcotics for maintenance treatment of opioid

addiction only via medication ordered and dispensed

from an “Opioid Treatment Program” (OTP)

• There is no “prescription” on a pad – medication is

ordered and dispensed from the OTP

• The DATA 2000 Act allows for physicians to obtain

waivers allowing limited prescribing of approved

narcotics less than Schedule II in other settings, such as

Office Based Opioid Treatment (OBOT)

11

What is special about OTPs?

Federal and State Requirements

• Full bio-psycho-social admission assessment, performed by nursing,

counselling and physician staff, including physical examination, drug

screens and laboratory work

• Admission only under a physician’s order

• Open 6-7 days per week with nurses on site each day

• Patient’s methadone doses are dispensed and consumed under

supervision of nurse/pharmacist (state rules vary)

Patients initially must come to clinic to dose daily

• Clinics licensed by state and feds, and accredited by either CARF or The

Joint Commission (prev. JCAHO)

12

What is special about OTPs?

Federal and State Requirements

• Required counselling for substance abuse (not synonymous with

psychotherapy for mental health issues)

• Documented full treatment planning

• Diversion control processes

Drugs screens (urine, oral swabs). Drug testing for confirmations if

necessary.

Urine collections may be observed or unobserved.

Call backs for both random urine drug screens (UDS) and to check

that any take home meds are accounted for

13

What is special about OTPs?

Federal and State Requirements

Gradual increase in take- home privileges

After several weeks / months (varies by state) of:

• Passed drug screens

• Perfect attendance

• Full adherence to treatment plan

Then patients may, under a physician’s order:

• Take home one fully labeled dose of methadone per week

14

What is special about OTPs?

Federal and State Requirements

• Earned number of days per week of take home

medications increase gradually by SAMHSA and state-

specific guidelines

• The maximum a patient may have under federal

guidelines is a 27 days supply per 28 days; may be

earned after a minimum of 2 years in treatment

15

Methadone and Buprenorphine

Similarities

• 1. Can cause withdrawal upon abrupt cessation

• 2. Have a range of dosing, which is titrated to the

individual patient’s needs

• 3. Relapse rates are high when treatment with

medication is discontinued

• 4. Patients can currently only be admitted to OTPs/

prescribed buprenorphine by physicians

16

What is special about OTPs?

• Around 1200 OTPs in the US

• Very few commercial health plans will contract with/ pay for OTP services

• Some urban areas have OTPs funded by block grants, other direct governmental funding, or Medicaid plans contracting with OTPs for services

• Meaning that typically OTPs operate on a patient self-pay model (daily or weekly payments)

Around $70-130/week, all required services and methadone medication included

17

What is special about OTPs?

• Methadone is dispensed, not prescribed

• Liquid, 40 mg wafers and/or 5 mg pills

10 mg pills may not be provided to/used by OTPs

10 mg pills found on the street were therefore initially

prescribed for pain, not dispensed by OTPs.

This has allowed the CDC to state clearly that the

vast majority of diverted methadone is not coming

from OTPs

• Stored in unrefrigerated safes

18

What is the “OTP Level of Care”?

• Outpatient care traditionally consists of such services as a 50 minute individual

therapy session, a 90 minute group therapy session, or a 15 minute medication

check by a prescriber. These typically occur 1-2 times per week, per month, or,

for fully stable patients, per quarter. (ASAM Level I)

• Intensive outpatient services are approximately 3 hours of service, three times a

week and may not include prescribing (ASAM Level II.1)

• Partial Hospital Programs are 4 hours a day, 5 days a week (ASAM Level II.2)

• Inpatient services range from medically intensive hospitalizations to

rehabilitation programs with no medical services included (ASAM Level III-IV)

19

What is the “OTP Level of Care”?

• “Opioid Maintenance Therapy” is a considered a

specific service that can be provided under any level

of care

• However, since most “OMT” is provided in “OTPs”, an

outpatient environment, criteria are provided in the

outpatient format

• The patient’s need for both high levels of structures

therapy and medication to prevent withdrawal

separate the OTP from outpatient levels of care

20

Historically, OTPs provided

methadone maintenance therapy

• Methadone has been the “Gold Standard” of care for opioid addiction for over 50 years

• Newer FDA approved medications, buprenorphine products (SL and buccal) and ER naltrexone, may be used outside of the OTP setting

• BUT - OTPs have a unique infrastructure which can be effectively utilized to provide all these mediation modalities

• Specific operational and clinical issues must be considered to integrate the full range of pharmacotherapies into the OTP setting

21

Methadone: Clinical issues

• Methadone is a full mu agonist with a long half life

• Once per day dosing for addiction, but 3-4 times daily dosing for chronic pain management. OTPs can only dose a patient qd without state exception to split into 2 doses

• Prolongs QTc with risk of Torsades de Pointes

• Meaningful peak and trough blood levels

• No ceiling effect on respiratory depression

Dangerous to titrate up quickly

Dangerous mixed with “The 3 Bs” - benzos/barbs/booze

22

Methadone: Clinical issues

• Uncomfortable and objectively obvious withdrawal

occurs after missing 1- 2 days of dose

• Requires daily dosing initially in the OTP

• Patient are not allowed to be in methadone

treatment and utilize a commercial driver’s license

• Patients who travel for work will need to either earn

take homes or guest dose at other facilities

23

Case (Part I)

Johnny is a 34 yo male; hurt back working in the coal

mines and was rxed opioids; use escalated and he

began using multiple oxycodone with APAP 30/500 mg

tabs through IV route daily. Meets criteria for Opioid

Dependence, LFTs less than 3x normal.

Tried buprenorphine from a clinic where he saw a

doctor and received a prescription: “It didn’t work for

me. I just stopped taking it and used, and took it some

more and then stopped and used. It was too easy to

game it. I need more. I don’t want that medicine”.

24

What patients may do well with

methadone treatment?

• Long hx of opioid addiction

• IV route of illicit drug administration

• Require diversion control procedures

• Respond to high levels of external daily structure

• Benefit from contingency management techniques

of the take home / phase system

25

Methadone and Buprenorphine

Similarities

1. Are daily dosed medication taken via the oral cavity

2. Can be stored in an unrefrigerated safe

3. Act to cover the mu receptor in order to:

i. Decrease or eliminate cravings

ii. Control physiological withdrawal

iii. Prevent euphoria from use of other mu agonists

26

Methadone and Buprenorphine

Similarities

1. Can cause withdrawal upon abrupt cessation

2. Have a range of dosing, which is titrated to the

individual patient’s needs

3. The endpoint of an episode of care consists of

gradual tapering to medication discontinuation

4. Patients can currently only be admitted to OTPs/

prescribed buprenorphine by physicians

27

Methadone and Buprenorphine

Similarities

1. Are mu receptor agonists (full and partial, respectively), and therefore can be

used by people not dosing daily with them to get high

2. Have significant street value when diverted

3. Can be lethal in overdose (low threshold for unintentional overdose seen in

adults due to long half-life and no respiratory depression ceiling;

buprenorphine fatalities have occurred in children or in other people without

tolerance)

4. Are seen as “using” by many 12 step groups; patients are often advised not to

tell others at meetings they are taking these medications

5. Stigma by some people in 12 step groups, criminal justice system, other

health care providers that these are “just substituting one drug for another’

28

Buprenorphine Issues in the OTP

• Buprenorphine may be obtained in 2 ways:

1. Prescribed by an OTP physician under their Data 2000 waver using OBOT restrictions ( 30/100 pt limit)

Or

2. Ordered and dispensed under methadone rules (full admission work up, daily supervised dosing, medication ordered and dispensed from the OTP, required counselling, drug screens, call backs, etc)

− EXCEPT: the time in treatment requirement to earn take home phases is not applicable under federal regs (states vary)

− As with methadone, there is no limit on the number of patients a physician may have on buprenorphine in an OTP ( states vary)

29

Buprenorphine Issues in the OTP

• OTP vs. OBOT in the clinic: It is either/or but not

both for a single patient during an episode of care.

Patients being prescribed buprenorphine by their

wavered physician may not be dosed at the OTP

unless they are first admitted and maintained

under OTP rules.

30

Buprenorphine Issues in the OTP:

Available Infrastructure

Although not required for OBOT, the OTPs have the ability to perform a variety of useful services for buprenorphine patients who require additional structure:

• Counseling

• Physical examinations

• Nursing services including observed dosing

• Diversion control processes

Drug screens/tests

Random call backs

Pill/film counts

31

Buprenorphine Issues in the OTP

1. Buprenorphine does not require as an careful induction because of ceiling effect on respiratory depression

2. Patients must have their mu receptors adequately “uncovered” by full mu agonist in order to begin dosing the partial agonist of buprenorphine, or they will be thrown into withdrawal

3. Because of the slow to absorb time SL vs. oral injestion of methadone, dosing SL buprenorphine can take significantly more staff time to monitor and ensure no diversion.

32

Case (Part II)

• Johnny did extremely well with methadone at a

maximum dose of 85 mg per day and began a gradual

dose reduction. At 3 years he on 70 mg and has been

eligible for 27 take homes per 28 days, but opts to get 13

in 14 days (“I don’t trust myself with more. I need to

come here to keep myself honest”)

• He has an opportunity to change jobs from underground

mining to hauling coal locally, which requires a

commercial driver’s license. He is willing to change to

buprenorphine, recognizing he is now doing well

presenting 2 weeks to clinic.

33

What patients may do well with

Buprenorphine?

1. Able to maintain treatment plan without daily

supportive contacts/ structure of clinic

i. Structure (employed, other)

ii. Strong sober support system

iii. Adequate stress management skills

Or OTP can order and dispense buprenorphine

under methadone rules

34

Overview of $ Issue

• Direct cost of methadone = <$1 a day

• Direct Cost of buprenorphine (SL) = $ 4 - $30 a day

• Direct Cost of ER naltrexone = $700-1000 per

injection ( monthly)

35

Buprenorphine Issues in the OTP:

Payment for Medication

• Buprenorphine retails $7-10 for 8 mg (with or without naloxone).

Health plans might/ might not cover buprenorphine

• Buprenorphine costs to OTP through a distributer might be < retail

But not <$1 per day as with methadone

• OTPs dispensing buprenorphine instead of methadone will need to cover the increased costs by:

increasing daily/weekly charges to the patient

billing medication costs directly to plans (such as by obtaining a pharmacy license)

36

Extended Release Naltrexone

• Full mu antagonist

• Blocks the high of using mu agonists

• Will precipitate withdrawal if agonists (full or partial)

are occupying mu receptors

7-10 days without other opioid use before

naltrexone

• Monthly dosing improves adherence

37

How ER naltrexone differs from

methadone and buprenorphine

• IM injection into buttocks

• Doses once monthly

• No abuse potential; not a scheduled narcotic

• Can be prescribed by advanced practice

nurses/physician assistants (varies by state)

• Specialty pharma product

• Medication must be refrigerated and mixed shortly

before administration

• Substantially less stigma

38

ER naltrexone OD risks

• Fatal overdoses have been reported in patients

taking ER naltrexone, especially when:

Trying to overcome opioid blockade

Using opioids at or near end of 1 month dosing

interval

Using opioids after missing dose

Patients may not understand their loss of tolerance

when taking ER naltrexone is a danger when they

lapse.

39

Case (Part III)

• Johnny made the change from methadone to buprenorphine,

stabilized at 12 mg qd for a year and gradually tapered to 4 mg

qd. Attempts to lower the dose have failed.

• Continues to choose present q 2 weeks to clinic, although

eligible for monthly visits and has been encouraged to find

support outside of clinic

• Local mines have closed, and he has the option for work in

another state. Plans to come home once monthly. Will have

insurance with new job, and has saved substantial money

since he stopped using street opioids and began treatment 6

years ago.

40

Which patients may do well with ER

naltrexone?

• High motivation for abstinence

Patients needing treatment where drug court

judges, professional boards, others may not allow

agonist tx

• Short/less severe hx of opioid addiction

• Failed agonist treatment

• Do not wish to use agonist tx

• Succeeded in agonist tx and want to change to less

intensive medication treatment regimen

41

How to Choose Medications?

• No evidence-informed guidelines on choosing the

three options currently

• Guidelines are being built by ASAM with date of

release mid-2015

• In lieu of formal guidelines, physicians must use

clinical judgment considering multiple issues

42

Choosing Medications

• Patient history of tx response/failure

• Family history of tx response/failure

• Patient’s / family’s beliefs about specific medications

• Patient’s financial ability to obtain

Medication itself

all services necessary to support a

medication treatment

43

Choosing Medications

• Restrictions due to professional boards/ employers/

family services or court representatives

• Potential for abuse/diversion

• Potential for drug interactions

• medical contraindication (relative or absolute )

• Patient’s access to OTP:

geographically

time constraints

transportation availability and cost

44

Operational Challenges Integrating all three medications into OTP setting

• Expanding safe storage for medications

Refrigeration for ER naltrexone

• “patient flow” - different times of day for different

medications? Recall slower buprenorphine SL

dosing flow

• Pricing new services

• Establish protocols for induction, maintenance, and

therapeutic discontinuation with buprenorphine and

ER naltrexone

45

Operational Challenges Integrating all three medications into OTP setting

• Relationships with payers and medication distributers

• New patient and family education materials

• New patient informed consent materials

• Education of all staff on all three modalities

• Education of community on availability of all three modalities

• Obtaining physician resources to lead clinical care in all modalities

• Probable availability of new buprenorphine formulations in near future

46

Conclusion

• OTPs offer a unique characteristics which can be

used to provide care with methadone,

buprenorphine, and ER naltrexone

• There are multiple clinical and operational

challenges in integrating all modalities

• All three FDA approved medications have unique

profiles which provide real treatment options for

patients

47

References

• ASAM Ppc-2R: ASAM Patient Placement Criteria for the Treatment of Substance-Related

Disorders. Editor David Mee-Lei . American Society of Addiction Medicine, 2001

• Substance Abuse and Mental Health Services Administration. (2012). An Introduction to

Extended-Release Injectable Naltrexone for the Treatment of People With Opioid

Dependence. Advisory, Volume 11, Issue 1.

• Center for Substance Abuse Treatment. (2009). Emerging Issues in the Use of

Methadone. HHS Publication No. (SMA) 09-4368. Substance Abuse Treatment Advisory,

Volume 8, Issue 1.

• Center for Substance Abuse Treatment. (2004). Clinical guidelines for the use of

buprenorphine in the treatment of opioid addiction. Treatment Improvement Protocol (TIP)

Series 40. HHS Publication No. (SMA) 04-3939. Rockville, MD: Substance Abuse and Mental

Health Services Administration.

• Center for Substance Abuse Treatment. (2008). Medication-assisted treatment for opioid

addiction in opioid treatment programs. Treatment Improvement Protocol (TIP) Series 43. HHS

Publication No. (SMA) 08-4214. Rockville, MD: Substance Abuse and Mental Health Services

Administration.

• Mattick, R. P., Breen C., Kimber J., & Davoli, M. (2009). Methadone maintenance therapy

versus no opioid replacement therapy for opioid dependence. Cochrane Database of

Systematic Reviews, Issue 3, Art. No.: CD002209. doi: 0.1002/14651858.CD002209.

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PCSS-MAT Mentoring Program

• PCSS-MAT Mentor Program is designed to offer general information to

clinicians about evidence-based clinical practices in prescribing

medications for opioid addiction.

• PCSS-MAT Mentors comprise a national network of trained providers with

expertise in medication-assisted treatment, addictions and clinical

education.

• Our 3-tiered mentoring approach allows every mentor/mentee relationship

to be unique and catered to the specific needs of both parties.

• The mentoring program is available, at no cost to providers.

For more information on requesting or becoming a mentor visit:

pcssmat.org/mentoring

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Funding for this initiative was made possible (in part) by Providers’ Clinical Support System for

Medication Assisted Treatment (1U79TI024697) from SAMHSA. The views expressed in written

conference materials or publications and by speakers and moderators do not necessarily reflect the

official policies of the Department of Health and Human Services; nor does mention of trade names,

commercial practices, or organizations imply endorsement by the U.S. Government.

PCSSMAT is a collaborative effort led by American Academy

of Addiction Psychiatry (AAAP) in partnership with: American

Osteopathic Academy of Addiction Medicine (AOAAM),

American Psychiatric Association (APA) and American Society

of Addiction Medicine (ASAM).

For More Information: www.pcssmat.org

Twitter: @PCSSProjects

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Please Click the Link Below to Access

the Post Test for the Online Module

Click Here to Take the Post Test

Upon completion of the Post Test:

• If you pass the Post Test with a grade of 80% or higher, you will be instructed to click a link

which will bring you to the Online Module Evaluation Survey. Upon completion of the

Online Module Evaluation Survey, you will receive a CME Credit Certificate or Certificate of

Completion via email.

• If you received a of 79% or lower on the Post Test, you will be instructed to review the

Online Module once more and retake the Post Test. You will then be instructed to click a

link which will bring you to the Online Module Evaluation Survey. Upon completion of the

Online Module Evaluation Survey, you will receive a CME Credit Certificate or Certificate of

Completion via email.

• After successfully passing, you will receive an email detailing correct answers,

explanations and references for each question of the Post Test.